UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062005 |
|---|---|
| Receipt number | R000070921 |
| Scientific Title | A Cross-Sectional Study Assessing the Prevalence of Islet-Related Autoantibodies in Japanese Individuals with Prediabetes Using Biobank Serum Samples |
| Date of disclosure of the study information | 2026/06/26 |
| Last modified on | 2026/06/19 19:58:43 |
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Basic information
Public title
A Cross-Sectional Study Assessing the Prevalence of Islet-Related Autoantibodies in Japanese Individuals with Prediabetes Using Biobank Serum Samples
Acronym
Aegis-T1D
Scientific Title
A Cross-Sectional Study Assessing the Prevalence of Islet-Related Autoantibodies in Japanese Individuals with Prediabetes Using Biobank Serum Samples
Scientific Title:Acronym
Aegis-T1D (Adult Early-stage T1D in dysGlycemic Status)
Region
| Japan |
Condition
Condition
Individuals who met the criteria of prediabetes at health check-up
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify individuals within the Japanese population with pre- diabetes, who are in the early stages of type 1 diabetes (T1D), and estimating their proportion.
Basic objectives2
Others
Basic objectives -Others
Proportion of individuals who test positive for islet-related autoantibodies among those identified as having pre-diabetes in health checkups.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of individuals who test positive for islet-related autoantibodies among those identified as having pre-diabetes in health checkups.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals who are registered in the St.Luke's International Hospital Biobank, meet the diagnostic criteria for prediabetes in the health check-up at St. Luke's International Hospital, and have stored serum samples available for use.
Individuals who are younger than 50 years of age at the time of registration.
Individuals who have following information recorded at the time of registration: age, sex, blood glucose level, HbA1c level, height, weight, Complete Blood Count (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT), self-reported history of pharmacological treatment.
Key exclusion criteria
Individuals who are receiving pharmacological treatment for diabetes at the time of registration.
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Oikawa |
Organization
Saitama Medical University
Division name
Department of Endocrinology and Diabetes
Zip code
350-0495
Address
38 Moro-Hongo, Moroyama-machi, Iruma-gun, Saitama Prefecture
TEL
049-276-1204
yoikawa@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Haruhisa |
| Middle name | |
| Last name | Okawa |
Organization
Sanofi K. K.
Division name
General Medicine Medical
Zip code
163-1488
Address
Tokyo Opera City Tower, 20-2 Nishi-Shinjuku 3-chome, Shinjuku-ku, Tokyo
TEL
080-6627-7026
Homepage URL
haruhisa.okawa@sanofi.com
Sponsor or person
Institute
Sanofi K.K.
Institute
Department
Personal name
Funding Source
Organization
Sanofi K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
St. Luke's International University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Luke's International University Research Ethics Committee
Address
10-1, Akashi-cho, Chuo-ku, Tokyo, Japan
Tel
03-5550-2423
kenkyukikaku@luke.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
study using biobank samples
Management information
Registered date
| 2026 | Year | 06 | Month | 22 | Day |
Last modified on
| 2026 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070921
